Bismarck, ND – North Dakota Attorney General Drew H. Wrigley has issued an urgent advisory warning residents across the state about companies promoting unproven stem cell treatments and other human tissue injections through sales presentations held at local restaurants. According to Wrigley, these companies make unsubstantiated claims that their therapies can relieve pain and potentially cure, treat, or mitigate a wide range of severe health conditions, including Parkinson’s disease, diabetes, multiple sclerosis, orthopedic problems, Alzheimer’s disease, autism, and dementia.
Wrigley stated that these promotional activities are false and misleading, posing a serious threat of both physical and financial harm to North Dakotans. He emphasized that it is unlawful under both state and federal law to sell such treatments without rigorous clinical testing and subsequent approval by the Food and Drug Administration (FDA).
While some companies might claim they use FDA-registered facilities or comply with FDA guidelines, the Attorney General clarified that this does not signify FDA approval for the marketed treatments. It also does not mean these companies adhere to federal requirements for safely producing and marketing their products. The FDA, Wrigley noted, has previously taken enforcement actions against companies marketing stem cell products without proper approval, warning that such practices risk patients’ safety. Additionally, the Federal Trade Commission (FTC) has identified similar sales presentations and claims regarding stem cell therapies as unfair and deceptive acts that violated federal law and injured consumers. Reported harms from the injection of unapproved stem cell products include life-threatening infections, chronic pain, and other serious health complications.
One specific company, Freedom Regenerative LLC, was highlighted in the advisory. This company sends mailers to North Dakota residents, inviting them to free dinner events where sales presentations are delivered. During these presentations, Freedom Regenerative LLC makes false and misleading promises of pain reduction or otherwise overstates the efficacy of the products it offers. The Attorney General’s office noted that Freedom Regenerative LLC conducted business in North Dakota without obtaining a transient merchant license, which is mandated by North Dakota law. The cost for the treatments offered by the company reportedly ranges between $9,000 and $29,000.
Attorney General Wrigley urged all consumers to consult with their primary physician before agreeing to purchase any alternative medical treatments advertised online or pitched through local sales presentations. Wrigley underscored the danger, stating there is “a cause for alarm” because these unproven products or therapies pose a significant risk to an individual’s health and financial well-being. He added that businesses making unsubstantiated claims and violating the law will face accountability, particularly when they target older adults and exploit a person’s pain or illness for personal gain.
Anyone with questions or who suspects they may have purchased stem cell treatment under misleading or inaccurate representations is encouraged to file a complaint. Complaints can be submitted to the Attorney General’s Consumer Protection and Antitrust Division at www.attorneygeneral.nd.gov or by calling 701-328-3404. The Attorney General’s Consumer Protection and Antitrust Division is dedicated to protecting North Dakota residents from misleading, deceptive, or unlawful practices related to the sale or advertisement of goods or services, by enforcing the state’s antitrust and consumer protection laws.
